Hazard

Lack Of Sterility recalls

1,423 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 1,423
Critical: 3
Severe: 1,055
Most recent: 2026-10-14

Of the 1,423 lack of sterility recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1,055 (74%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all lack of sterility recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1401–1423 of 1423

SevereFDA (Drugs)·D-348-2013·2013-05-22
Green Valley Drugs Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-370-2013·2013-05-22
Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns
Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-367-2013·2013-05-22
Green Valley Drugs Recalls Furosemide Injection Due to Sterility Concerns
Green Valley Drugs is recalling Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.
Product
Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-401-2013·2013-05-22
Green Valley Drugs Recalls Procaine Hydrochloride Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-381-2013·2013-05-22
Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns
Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections nationwide due to a lack of assurance of sterility.
Product
Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-340-2013·2013-05-22
Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.
Product
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-390-2013·2013-05-22
Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.
Product
Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-412-2013·2013-05-22
Green Valley Drugs Recalls Sterile Testosterone and Nandrolone Injections
Green Valley Drugs is recalling specific lots of sterile hormone injections due to a lack of assurance of sterility and quality control concerns.
Product
Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-283-2013·2013-05-01
BiMix Standard Injectable Recalled for Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling BiMix Standard Injectable due to lack of sterility assurance and quality control concerns.
Product
BiMix Standard Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-273-2013·2013-05-01
Betamethasone Injectable Recalled Due to Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling Betamethasone Injectable due to lack of sterility assurance and quality control concerns.
Product
Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-292-2013·2013-05-01
HCG Lyophilized Powder Recalled for Lack of Sterility Assurance
Axium Healthcare Pharmacy is recalling HCG Lyophilized Powder 10,000 unit for Injectable due to lack of sterility assurance. The product was distributed in Colorado, Georgia, Michigan, and Puerto Rico.
Product
HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-274-2013·2013-05-01
Axium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns
Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.
Product
Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Category
Drug
Distribution
4 states
SevereFDA (Drugs)·D-119-2013·2013-01-09
New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns
New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.
Product
Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-117-2013·2013-01-09
New England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns
New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.
Product
Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-113-2013·2013-01-09
Betamethasone Sodium Phosphate Injection Recalled for Sterility Concerns
New England Compounding Center is recalling Betamethasone Sodium Phosphate injections due to a lack of assurance of sterility.
Product
Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-124-2013·2013-01-09
New England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns
New England Compounding Center is recalling specific Triamcinolone vials nationwide because the company cannot guarantee the products are sterile.
Product
Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-052-2013·2012-11-21
Sterile Products from New England Compounding Center Recalled Due to Sterility Concerns
New England Compounding Center is recalling all of its sterile products because the company cannot assure that the products are sterile.
Product
All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1591-2012·2012-08-22
Franck's Lab Recalls Sterile Paclitaxel Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Paclitaxel injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1500-2012·2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Product
DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1593-2012·2012-08-22
Franck's Lab Recalls Sterile Papaverine HCL Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile Papaverine HCL injectable vials because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 ML (2 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1585-2012·2012-08-22
Franck's Compounding Lab Recalls Morphine Sulfate Injectable Products
Franck's Compounding Lab is recalling 92 units of morphine sulfate injectable products due to a lack of assurance of sterility.
Product
MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1465-2012·2012-08-22
Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Product
BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1446-2012·2012-08-15
Nephron Recalls Albuterol Sulfate Inhalation Solution Due to Sterility Concerns
Nephron Pharmaceuticals is recalling Albuterol Sulfate Inhalation Solution because the company cannot ensure the product is sterile. The recall affects 56,028 cartons distributed nationwide and in Puerto Rico.
Product
ALBUTEROL SULFATE — ALBUTEROL SULFATE (ALBUTEROL SULFATE)
Category
Drug
Distribution
Distributed nationwide